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KCD (Carfilzomib/Cyclophosphamide/Dexamethasone) Regimen for the Treatment of Newly Diagnosed POEMS Syndrome

16 giugno 2026 aggiornato da: Haiyan He, Shanghai Changzheng Hospital

A Single-center, Prospective, Open-label Investigation of the KCD (Carfilzomib/Cyclophosphamide/Dexamethasone) Regimen for the Treatment of Newly Diagnosed POEMS Syndrome

This study is a single-center, prospective, open-label clinical study to evaluate the efficacy and safety of KCD(Carfilzomib/Cyclophosphamide/Dexamethasone) regimen in subjects with newly diagnosed POEMS Syndrome.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Descrizione dettagliata

POEMS syndrome is a rare plasma cell disorder, with an incidence of approximately 0.3 per 100,000 individuals. Its typical clinical manifestations encompass peripheral neuropathy, organomegaly, endocrine abnormalities, M -proteinemia, and cutaneous alterations, frequently accompanied by papilledema, fluid retention, thrombocytosis, osteosclerosis, and elevated levels of vascular endothelial growth factor (VEGF). Plasma cell clonal proliferation and VEGF overexpression are regarded as the key pathogenic mechanisms of POEMS syndrome. Currently, there is no standardized treatment protocol for POEMS syndrome, and anti-plasma cell therapy remains the primary therapeutic approach. Clinically recommended treatments involve alkylating agents, immunomodulators, proteasome inhibitors, and autologous hematopoietic stem cell transplantation (ASCT). Carfilzomib, a second-eneration proteasome inhibitor, has been extensively utilized in multiple myeloma. The evidence supporting the use of carfilzomib in POEMS syndrome is restricted to case reports and small-scale retrospective studies, and prospective clinical trials evaluating carfilzomib-based regimens as first-line therapy are still lacking. Therefore, this study designed a centralized, prospective, open-label clinical trial to evaluate the KCD regimen(carfilzomib + cyclophosphamide + dexamethasone) in patients with newly-diagnosed POEMS syndrome. This study plans to enroll 20 subjects, all subjects will receive KCD regimen for 6-8 cycles. The primary endpoints include overall hematological response rate, neurological response rate, and vascular endothelial growth factor (VEGF) response rate. Secondary endpoints include hematological and non-hematological toxicities, progression-free survival (PFS), and overall survival (OS).

Tipo di studio

Interventistico

Iscrizione (Stimato)

20

Fase

  • Fase 2

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

  • Nome: Xuerou Yu

Luoghi di studio

      • Shanghai, Cina
        • Reclutamento
        • Shanghai Changzheng Hospital

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

Inclusion Criteria:

  1. Newly diagnosed POEMS syndrome meeting the Dispenzieri diagnostic criteria (2023 version);
  2. Age 18-75 years;
  3. ECOG performance status 0-3, with an estimated life expectancy >3 months;
  4. No active infective diseases;
  5. No prior anti-POEMS therapy except for corticosteroids;
  6. No severe organic impairment of major organs, meeting the following laboratory requirements: creatinine clearance ≥40 mL/min, total bilirubin ≤1.5 × upper limit of normal (ULN); AST and ALT ≤2.5 × ULN; cardiac enzymes <2 × ULN; left ventricular ejection fraction within normal range on echocardiography, and no clinically significant electrocardiogram abnormalities;
  7. Absolute neutrophil count ≥1.5 × 10^9/L without prior growth factor support; platelet count ≥50 × 10^9/L without platelet transfusion within 7 days prior to screening; hemoglobin ≥60 g/L;
  8. Ability to swallow and take medication orally;
  9. Completion of all screening and assessments as outlined in the study protocol;
  10. Signed informed consent for chemotherapy.

Exclusion Criteria:

  1. POEMS syndrome complicated by multiple myeloma, light chain amyloidosis, or Waldenström macroglobulinemia;
  2. HIV positivity, or active hepatitis A, hepatitis B, or hepatitis C infection; or hepatitis B virus DNA >10^2 copies/mL;
  3. Concurrent severe unstable medical conditions, including heart failure, renal failure, liver failure, bleeding disorders, arterial/venous thrombotic events within 6 months, uncontrolled diabetes mellitus, or a history of active hemorrhagic cystitis;
  4. History of autoimmune diseases (e.g., Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus) within the past 2 years that caused end-organ damage or required systemic immunosuppressive or disease-modifying therapy;
  5. Severe active infections (e.g., untreated tuberculosis, pulmonary aspergillosis);
  6. Presence of other malignancies (except non-melanoma skin cancer, in situ cervical, bladder, or breast cancer with disease-free survival >5 years);
  7. Epilepsy requiring medication, dementia, or other mental status abnormalities that interfere with understanding or complying with the study protocol;
  8. Drug use, medical, psychological, or social conditions that may interfere with study participation or outcome assessment;
  9. Pregnancy or breastfeeding;
  10. Any condition deemed by the investigator to make the patient unsuitable for enrollment.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: N / A
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: carfilzomib, cyclophosphamide and dexamethasone
carfilzomib at a dose of 27 mg/m2 (20 mg/m2 only in the first infusion) intravenously (iv) on days 1, 8, and 15, cyclophosphamide at a dose of 200 mg/m2 iv on days 1, 8 and 15, and dexamethasone at a dose of 20 mg (10 mg for patients >75 years) days 1, 2, 8, 9, 15 and 16 in 28 days cycles
carfilzomib at a dose of 27 mg/m2 (20 mg/m2 only in the first infusion) intravenously (iv) on days 1, 8, and 15,cyclophosphamide at a dose of 200 mg/m2 iv on days 1, 8 and 15 and dexamethasone at a dose of 20 mg (10 mg for patients >75 years) days 1, 2, 8, 9, 15 and 16
Altri nomi:
  • KCD

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Overall hematological response rate
Lasso di tempo: 2 years

hematological response rate:

  • Complete Remission (CR_H): Normal bone marrow; negative serum and urine immunofixation electrophoresis; disappearance of M-protein.
  • Very Good Partial Remission (VGPR_H): Reduction of M-protein by >90% (baseline M-protein ≥5 g/L).
  • Partial Remission (PR_H): Reduction of M-protein by ≥50% (baseline M-protein ≥10 g/L).
  • No Response (NR_H): Failure to meet criteria for PR_H.
  • Progressive Disease (PD): Reappearance of M-protein in serum and/or urine, or an increase of >25% from the lowest level (with absolute M-protein increase ≥5 g/L).
2 years
Overall VEGF response rate
Lasso di tempo: 2 years

VEGF response rate:

  • Complete Remission (CR_V): Normalization of serum VEGF (elevation typically defined as serum VEGF >2 times the upper limit of normal).
  • Partial Remission (PR_V): Reduction of VEGF by ≥50%.
  • No Response (NR_V): Failure to meet criteria for PR_V.
  • Progressive Disease (PD): Persistent (≥2 consecutive measurements) elevation of VEGF , or persistent elevation of VEGF by 50% from the post-treatment nadir.
2 years
Overall neurological response rate
Lasso di tempo: 2 years

Neurological response rate:

Neurologic improvement assessed by neurophysiologic examination, modified Rankin Scale, or Overall Neuropathy Limitations Scale (ONLS).

  1. Complete response: 0 point;
  2. Improvement: Improved by 1 point;
  3. Progression: Worsened by 1 point
2 years

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
the incidence of adverse events and severe adverse events
Lasso di tempo: 2 years

Major Adverse Events

  1. Hematologic toxicity: neutropenia, thrombocytopenia, etc.
  2. Infections: bacterial pneumonia, sepsis, etc.
  3. Worsening of neuropathy
  4. Capillary leak syndrome
  5. Thrombotic events Grading and Definition of Serious Adverse Event All adverse events are graded according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Gr
2 years
the 2-year overall survival rate
Lasso di tempo: 2 years
Two-year overall survival (2-year OS) is defined as the proportion of patients who remain alive at two years following the start of treatment (or from the date of diagnosis).
2 years
Two-year progression-free survival
Lasso di tempo: 2 years
Two-year progression-free survival (2-year PFS) is defined as the proportion of patients who remain alive and have not experienced disease progression at two years following the start of treatment (or from the time of diagnosis)
2 years

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

  • Investigatore principale: Haiyan He, Dr., Shanghai Changzheng Hospital

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

15 giugno 2026

Completamento primario (Stimato)

1 gennaio 2028

Completamento dello studio (Stimato)

1 gennaio 2028

Date di iscrizione allo studio

Primo inviato

24 maggio 2026

Primo inviato che soddisfa i criteri di controllo qualità

16 giugno 2026

Primo Inserito (Effettivo)

17 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

17 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

16 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano IPD

POEMS syndrome is a rare disease, and its clinical data are highly valuable

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Prove cliniche su CARFILZOMIB, CYCLOPHOSPHAMIDE, DEXAMETHASONE

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